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Active, Not Recruiting

NCT Number: NCT03251118

A 5-year Longitudinal Observational Study of Patients Undergoing Therapy for Inflammatory Bowel Disease

TARGET-IBD is a 5-year, longitudinal, observational study of adult and pediatric patients (age 2 and above) being managed for Inflammatory Bowel Disease (IBD) in usual clinical practice. TARGET-IBD will create a research registry of patients with IBD within academic and community real-world practices in order to assess the safety and effectiveness of current and future therapies.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Inflammatory Bowel Diseases Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Crohn's Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Indeterminate Colitis Intestinal Diseases Ulcerative Colitis

Age range

2 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Om Research, Lancaster, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults and children (age 2 or older) with a diagnosis of Crohn's disease (CD), Ulcerative colitis (UC), or Indeterminate colitis (IBDU) having been prescribed any IBD treatment (initial or subsequent) outside of a clinical trial.
  • Have plans for future visits at the site for continued management of IBD.

Exclusion criteria

  • Inability to provide written informed consent/assent.
  • Being enrolled in any interventional study or trial for IBD treatment. Note: Patient may be enrolled in other registries or studies where IBD treatment outcomes are observed and/or reported (such as center-based registries).
  • Prior total abdominal colectomy for UC or IBDU.

Treatment and study plan

Primary outcomes

  1. Natural history of Inflammatory Bowel Disease: Characteristics of IBD

    Time frame: Up to 5 years

  2. Natural history of Inflammatory Bowel Disease: Participant demographics

    Time frame: Up to 5 years

  3. Natural history of Inflammatory Bowel Disease: Treatment use

    Time frame: Up to 5 years

  4. Natural history of Inflammatory Bowel Disease: Treatment response

    Time frame: Up to 5 years

  5. Natural history of Inflammatory Bowel Disease: Disease progression

    Time frame: Up to 5 years

Secondary outcomes

  1. Endoscopic measures of mucosal healing

    Time frame: Up to 5 years

  2. Adverse event frequency and severity

    Time frame: Every 3 months for 5 years

  3. Timepoint of clinical response

    Time frame: Every 3 months for 5 years

  4. Timepoint of endoscopic response

    Time frame: Up to 5 years

  5. Reasons for treatment discontinuation

    Time frame: Up to 5 years

  6. Self-reported patient health measures: EQ-5D

    Time frame: Every 3 months for 5 years

  7. Self-reported patient health measures: PRO-2 for Crohn's Disease

    Time frame: Every 3 months for 5 years

  8. Self-reported patient health measures: PRO-2 for Ulcerative colitis

    Time frame: Every 3 months for 5 years

  9. Self-reported patient health measures: 2-question Adherence Measure

    Time frame: Every 3 months for 5 years

  10. Self-reported patient health measures: Manitoba IBD Index (MIBDI)

    Time frame: Every 3 months for 5 years

  11. Self-reported patient health measures: Pediatric Ulcerative colitis Activity Index (PUCAI)

    Time frame: Every 3 months for 5 years

  12. Timepoint of endoscopic remission

    Time frame: Up to 5 years

Sponsors and collaborators

Lead sponsor

Target PharmaSolutions, Inc.

Industry

Registry information

Acronym: TARGET-IBD

Important dates

Study start
2017
Primary completion
2027
Study completion
2027
First posted
Aug 16, 2017
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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